Before any promising discovery can be tested in patients, researchers must obtain approval from various regulatory bodies, like the Food and Drug Administration (FDA), to ensure that the research plan (protocol) meets strict requirements for study design, safety, and integrity of data collection. Adequately addressing the multitude of regulatory questions can mean all the difference between getting a green light to proceed or facing continuous critique and rejection.
To help navigate the regulatory roadmap, DRI scientists turn to Dr. Khemraj “Raj” Hirani, Director of Regulatory Affairs and Quality Assurance, and his team. Dr. Hirani, who also serves as Associate Vice Provost for Human Subject Research at the University of Miami Miller School of Medicine, has an extensive background in all matters related to regulatory affairs, clinical trials, FDA submissions, research compliance and more. His guidance and expertise has become increasingly important as many of the DRI’s research initiatives move into the clinical trial phase of testing.
Dr. Hirani’s passion for advancing transformative therapies for the cure of type 1 diabetes is both professional and personal: he wants nothing more than to see a cure for his 7-year-old son and millions like him.
What is your role at the DRI?
I represent the Regulatory Affairs and Quality Assurance unit where we provide strategic leadership, coordination, and support that will advance the DRI’s ability to develop a cure for type 1 diabetes. My team’s function is to provide regulatory support concerning FDA-regulated products. The area of our focus is large and includes helping to evaluate the quality, safety, and effectiveness of DRI’s discoveries.
Specifically, in my role as Director, I serve as the liaison between the DRI’s multidisciplinary team of scientists and the regulatory agencies in moving through the clinical trial process. Regulatory Affairs is particularly enjoyable for me, as I find it very rewarding both professionally and personally in helping to bridge the gap between DRI’s pre-clinical scientists, surgeons, endocrinologists, immunologists, statisticians and other team members in developing protocols that advance knowledge toward cure of t1D but also respect the fundamental rights of our patients.
What are the most exciting and challenging parts of your job?
For me, the most exciting part is that the science created at the DRI is progressing at the speed of light. There are so many new pathways and new mechanisms to explore on an almost daily basis. The biggest challenge we face is the complex scientific basis of this disease that makes it so hard to cure. We have to test many ideas in our work, and conducting clinical trials in the regulatory environment is very challenging. When I get discouraged, I just think of my son and it helps to renew my passion for my work.
What makes working at the DRI special?
One of my goals is to see my son and the millions like him cured of this disease. When a disease hits home, it hits the hardest, and working at the DRI with those who have type 1 diabetes makes me constantly realize how hard we have to fight to cure it. The DRI is such a unique place in that its number one mission is to cure this disease and help those suffering from it. Its multidisciplinary research focus embraces openness and diversity of thought, bringing those living with the disease to the heart of its mission. This creates an unparalleled synergistic boost that binds the research team and its patients together. I have lived and worked in many professional organizations and in different countries, I am most happy though to now call the DRI my professional home.
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Lori Weintraub, APR